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The changing face of clinical trial services

A contract packager examines trends affecting the pharmaceutical industry.

BLISTER PACK. This compliance-prompting pack for a clinical trials application includes room for patient initials and date dispensed.
BLISTER PACK. This compliance-prompting pack for a clinical trials application includes room for patient initials and date dispensed.

The competitive landscape for pharmaceutical and biotech companies is different today than in years past. We operate in a truly global market and thus healthcare pressures are felt not only from the markets of traditional developed countries, but across the globe. Every day we read about a new development, including ongoing M&A activity creating industry consolidation, challenges, and opportunities created by drugs going off patent, the rise in affluence of developing countries, the potential for growth in emerging markets, and healthcare reform efforts in the U.S. and abroad. 

The economic pressures on the industry have had dramatic effects on the pipeline development of major drug companies. With the extraordinary costs associated with bringing a compound from discovery to commercialization, a tremendous amount of scrutiny is placed on drug candidates at each phase of clinical development. The result is that companies have significantly narrowed their pipelines. 

This has given rise to startup companies, often funded by venture capital, that give their undivided attention to developing only a handful of molecules or sometimes even a single product. If they succeed, they can be assured that the major pharmaceutical companies will either partner or acquire their company to help shore up their own pipelines. We see firms both large and small also focusing on narrow therapeutic indices or developing orphan products to assure timely approval for commercialization. The U.S. Food and Drug Assn. has set precedent that expedited review will be granted for companies developing products for unmet need.  While the patient populations for these products may be relatively small compared to the blockbusters of years prior, the value of the products are significant and competition from products is limited.

The changing face of the pharmaceutical industry has created an evolution in the clinical services industry. Because of the time it takes to develop drug products, there is tremendous pressure to expedite products through the clinical phases and bring them to commercialization. This is a balancing act, as firms need to ensure they have data to demonstrate robust safety and efficacy, while at the same time maximizing speed-to-market and return on the investment for each study, at each phase of clinical development.

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